Pharmaceutical Technology

SEPTEMBER 16, 2022

The Australian Therapeutic Goods Administration (TGA) has granted provisional approval for Specialised Therapeutics’ targeted therapy, Pemazyre (pemigatinib), for the treatment of cholangiocarcinoma, a rare bile duct cancer. The trial assessed the efficacy and safety of Pemazyre in adult patients.

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pharmaphorum

JANUARY 21, 2022

To date, clinical studies have shown that it is safe and well-tolerated in humans and is easily administered orally. Pre-clinical studies demonstrate that inhibition of CK2 by Silmitasertib prevents DNA repair, induces apoptosis, and improves the antitumor activity of gemcitabine and cisplatin,” states Senhwa.

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pharmaphorum

JULY 22, 2021

Incyte’s Pemazyre has become the first targeted therapy available for NHS patients with cholangiocarcinoma or bile duct cancer, after NICE concluded it provided value for money. NICE estimates that around 50 of them will qualify for treatment with Pemazyre.

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Pharmaceutical Technology

FEBRUARY 15, 2023

Kinnate Biopharma has received Fast Track designation from the US Food and Drug Administration (FDA) for its pan-FGFR inhibitor, KIN-3248, to treat unresectable, locally advanced or metastatic cholangiocarcinoma (CCA). The company is now evaluating KN-4802 in an ongoing open-label, multi-centre, two-part clinical trial.

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European Pharmaceutical Review

OCTOBER 9, 2023

Through this acquisition, Bristol Myers Squibb also gains access to several promising clinical assets from Mirati including MRTX1719, a potential first-in-class MTA-cooperative PRMT5 inhibitor in Phase I development. The treatment has shown encouraging early efficacy data in NSCLC, bile duct cancer (cholangiocarcinoma) and melanoma.

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Pharmaceutical Technology

MAY 31, 2023

Sym-021 is under clinical development by Les Laboratoires Servier and currently in Phase I for Solid Tumor. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The therapeutic candidate targets immune checkpoint, programmed cell death protein 1 (PD1).

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Pharmaceutical Technology

FEBRUARY 19, 2023

LYT-200 is under clinical development by Puretech Health and currently in Phase II for Metastatic Pancreatic Cancer. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It is also evaluating LYT-300, oral allopregnanolone for neurological indications.

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pharmaphorum

DECEMBER 21, 2022

months in patients with range of BTC subtypes, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer, who typically have a poor prognosis and limited treatment options.

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Pharmaceutical Technology

FEBRUARY 19, 2023

Annexuzlimab is under clinical development by MedAnnex and currently in Phase I for Kidney Cancer (Renal Cell Cancer). Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It also provides non-clinical testing programs.

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Pharmaceutical Technology

SEPTEMBER 30, 2022

Phase I clinical trials of SynKIR-110 in mesothelin-expressing mesothelioma, cholangiocarcinoma and ovarian cancer patients will begin in the first quarter of next year. The latest development comes after the US FDA granted clearance for Verismo’s Investigational New Drug (IND) application to begin the Phase I STAR-101 trial.

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Pharmaceutical Technology

JANUARY 2, 2023

Lifirafenib maleate is under clinical development by BeiGene and currently in the Phase II in clinical pathway. GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Lifirafenib maleate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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PharmaShots

JUNE 26, 2023

in clinical studies. in clinical studies. for LA or metastatic cholangiocarcinoma with an IDH1 R132 mutation The approval was based on the results from the P-III study (AGILE) in AML, published in the NEJM evaluating Tibsovo + azacitidine vs PBO + azacytidine which showed an improvement in EFS & OS, m-OS (24.0 vs 7.9mos.)

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PharmaShots

JUNE 15, 2023

Philippe Halfon: We are delighted to be collaborating with Grenoble University Hospital, an institution involved in a number of major clinical trials in oncology, specifically promoting ABE-LIVER, thanks to its active network in the area of liver cancer. Smriti: Brief about your collaboration with Grenoble University Hospital.

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PharmaShots

APRIL 21, 2023

Oblato Reports the First Patient Enrolment of OKN-007 in the P-I Clinical Trial for Recurrent High-Grade Glioma Date: Apr 21, 2023 | Tags: Oblato, OKN-007, Recurrent High-Grade Glioma, Regulatory, Henry Ford Health System CARsgen's CT041 Receives the US FDA’s IND Clearance for the Postoperative Adjuvant Therapy of Pancreatic Cancer Date: (..)

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pharmaphorum

OCTOBER 25, 2021

One type called cholangiocarcinoma is particularly prevalent in China but is on the rise in western countries, while another form – gallbladder cancer – is more common in South America, India and Japan. Details of the data will be presented at a future cancer conference.

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Pharmaceutical Technology

JUNE 5, 2023

Pralsetinib is under clinical development by F. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Hoffmann-La Roche and currently in Phase II for Pancreatic Cancer. Pralsetinib overview Pralsetinib (Gavreto) is an anticancer agent.

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PharmaShots

MAY 12, 2023

Difficile Infection at DDW 2023 Date: May 08, 2023 | Tags: Seres Therapeutics, Nestlé Health Science, Vowst, Recurrence of C.

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Pharmaceutical Technology

JUNE 6, 2023

According to Globaldata, it is involved in 5 clinical trials, which are ongoing. The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress. Buy the model here.

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Digital Pharmacist

OCTOBER 24, 2022

The FDA has approved Lytgobi tablets for the treatment of adult patients with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 gene fusions or other rearrangements. following data from the CENTAUR Phase 2 Clinical Trials. .

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European Pharmaceutical Review

OCTOBER 25, 2023

Clinical evidence for Tibsovo This new US approval for Tibsovo was based on data from an open-label, single-arm, multi-centre Phase I study. The small molecule treatment Tibsovo (ivosidenib) is the first targeted therapy approved for this indication.

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Pharmaceutical Technology

AUGUST 29, 2022

The approval was based on findings from the multicentre, open-label, single-arm Phase II FIGHT-203 clinical trial that assessed the safety and efficacy of Pemazyre in 28 adult patients with r/r MLNs with FGFR1 rearrangement. Pemazyre is a selective fibroblast growth factor receptor (FGFR) inhibitor for various indications.

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Pharmaceutical Technology

MARCH 2, 2023

Pembrolizumab is under clinical development by Merck and currently in Phase III for Bile Duct Cancer (Cholangiocarcinoma). According to GlobalData, Phase III drugs for Bile Duct Cancer (Cholangiocarcinoma) have a 53% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration.

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Pharmaceutical Technology

APRIL 6, 2023

Clinical programs which are granted this designation may also apply for accelerated approval and priority review, subject to meeting relevant criteria. SynKIR-110 is an investigational drug to treat serious diseases and life-threatening conditions, specifically mesothelin-expressing mesothelioma, ovarian cancer and cholangiocarcinoma.

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